A Phase 3 Trial in Bowel Preparation for Colonoscopy

NCT05870553 | Completed Phase 3

• 1 other identifier: CTP0301
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Successful Bowel Cleansing (Overall Colon)

  The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful.

  1 day of scheduled colonoscopy

Secondary Outcomes (1)

• Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

  1 day of scheduled colonoscopy

Study Arms (3)

CTP0301-A

EXPERIMENTAL

Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy.

Drug: CTP0301-A

CTP0301-B

EXPERIMENTAL

Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy.

Drug: CTP0301-B

Cool prep

ACTIVE COMPARATOR

Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy.

Drug: Cool prep

Interventions

CTP0301-A DRUG

Bowel Preparation

Also known as: PEG 3350

CTP0301-A

CTP0301-B DRUG

Bowel Preparation

Also known as: PEG 3350

CTP0301-B

Cool prep DRUG

Bowel Preparation

Also known as: PEG 3350

Cool prep

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients and inpatients aged: ≥19
• A prospective colonoscopy person
• Written informed consent to participate in the trial

You may not qualify if:

• Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
• Patients with ongoing severe acute Inflammatory Bowel Disease.
• Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
• Pregnant women or pregnant women or pregnant women
• Severe heart disease (cardiac failure (NYHA class 3 and 4))
• Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
• People who have hypersensitivity or allergies to clinical trial drug components.

Sponsors & Collaborators

• Taejoon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

Location

MeSH Terms

Interventions

polyethylene glycol 3350

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 23, 2023
• Study Start: January 30, 2023
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)